Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

To join this study, you must be at least 18 years old and have been diagnosed with an advanced liver cancer (hepatocellular carcinoma) or bile duct cancer (biliary tract cancer) that has been confirmed by examining tissue samples. You also need to be well enough generally, meaning your main bodily functions like your blood, liver, and kidneys are working adequately. It's important that you have at least one measurable area of cancer that hasn't been treated with radiation before, and doctors believe you have a life expectancy of at least 12 weeks. You'll also need to be able to provide a sample of your tumour tissue for testing.

There are certain reasons why you wouldn't be able to join. For example, if you've had an organ transplant, have certain autoimmune conditions (where your body's immune system attacks itself), or an uncontrolled illness. You also can't have other active cancers, certain severe infections, or cancer that has spread to the brain or spinal cord. If you have both Hepatitis B and Hepatitis D, you won't be able to participate. Also, if you've had a liver problem called hepatic encephalopathy in the past year (for those with liver cancer specifically), or if you've already received treatment in this specific study before, you wouldn't be eligible.

If you join this study, you will be assigned to receive either one of the new immunomodulator drugs on its own or in combination with other known cancer treatments. The study is divided into different 'substudies'. For example, if you have advanced liver cancer, you might be in a group of about 200 people. If you have advanced bile duct cancer and haven't had previous treatment for advanced disease, you might be in a group of about 90 people receiving a specific combination of drugs. The exact details of your visits, assessments (like blood tests or scans), and how long you'll be on the treatment will be explained fully by the study team. You'll have regular check-ups to monitor your health, how the treatment is working, and any side effects. The total duration of your participation will depend on your individual response to the treatment and the study plan, but you will be closely monitored throughout.